Introduction to Medical Devices: Development and Context

This talk and discussion will provide students with an overview of the medical device development process, how key considerations are different for devices and drugs, how the development process is evolving, and important non-technical considerations.

Frederick J. Schoen is Director of the BWH Biomedical Research Institute (BRI) Technology and Innovation Initiative and BWH liasion to (Site Miner for) the Center for Integration of Medicine and Innovative Technology (CIMIT). He is also Professor of Pathology and Health Sciences and Technology, Harvard Medical School and Executive Vice-Chairman in the Department of Pathology at BWH.

Schoen has leadership responsibilities in academic programs in the Department of Pathology, Harvard Medical School and the Harvard-MIT Division of Health Sciences and Technology (HST) and is an active teacher/director of courses in pathology, cardiovascular pathology, biomaterials, tissue engineering, and medical device development at Harvard, MIT, and the Harvard Catalyst. Dr. Schoen’s research is in cardiovascular pathology, heart valve substitutes, biomaterials and tissue engineering. His activities entail considerable interaction with industry, technology transfer, venture capital and regulatory scientists and other non-academic personnel related to the the furthering and translation of biomedical science.

Schoen earned a PhD in Materials Science from Cornell University (1970) and an MD from the University of Miami School of Medicine (1974). Following a Surgery internship, residency in Anatomic Pathology and fellowship in Thoracic and Cardiovascular Pathology, he joined BWH and Harvard Medical School in 1980.